Trial Outcomes & Findings for Impact on Management of the HEART Risk Score in Chest Pain Patients (NCT NCT01756846)

Results Overview

occurrence of major adverse cardiac events (MACE, i.e. acute myocardial infarction (AMI), Percutaneous Coronary Intervention (PCI), Coronary Artery Bypass Grafting (CABG) or death) within 6 weeks after presentation

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

3666 participants

Primary outcome timeframe

6 weeks

Results posted on

2019-01-25

Participant Flow

Inclusion at 9 Dutch Emergency departments, recruitment period between 1-7-2013 and 31-8-2014.

Exclusion criteria were evident ST-segment elevation myocardial infarction, language barriers, recurrent presentation, or unable or unwilling to give informed consent.

Participant milestones

Participant milestones
Measure	Usual Care usual care was defined as daily practice of the cardiologist or attending emergency doctor, in order to diagnose a patient with chest pain. In this period attending doctors assess the risk of a patient with chest pain, based on his/hers experience and various criteria (for example described in European Society of Cardiology Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation, without a formal risk score).	HEART Care HEART care: usual care, complemented by calculation of the HEART score and following the recommended policy. During 14 months, patients presenting with chest pain to the emergency department (ED) of participating hospitals were included in the study. First, all hospitals applied 'usual care' to all patients, i.e. risk assessment and subsequent management without application of the HEART score. Then, during a 14 month period, each 1,5 month 1 randomly allocated hospital sequentially started to apply the HEART score in all chest pain patients (intervention period); during this intervention period patients with a HEART score 0-3 were advised not be admitted to the hospital, and patients with a HEART score above 3 were advised to be treated according to current guidelines.
Overall Study STARTED	1833	1833
Overall Study COMPLETED	1827	1821
Overall Study NOT COMPLETED	6	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Usual Care usual care was defined as daily practice of the cardiologist or attending emergency doctor, in order to diagnose a patient with chest pain. In this period attending doctors assess the risk of a patient with chest pain, based on his/hers experience and various criteria (for example described in European Society of Cardiology Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation, without a formal risk score).	HEART Care HEART care: usual care, complemented by calculation of the HEART score and following the recommended policy. During 14 months, patients presenting with chest pain to the emergency department (ED) of participating hospitals were included in the study. First, all hospitals applied 'usual care' to all patients, i.e. risk assessment and subsequent management without application of the HEART score. Then, during a 14 month period, each 1,5 month 1 randomly allocated hospital sequentially started to apply the HEART score in all chest pain patients (intervention period); during this intervention period patients with a HEART score 0-3 were advised not be admitted to the hospital, and patients with a HEART score above 3 were advised to be treated according to current guidelines.
Overall Study Lost to Follow-up	5	10
Overall Study Withdrawal by Subject	1	2

Baseline Characteristics

Impact on Management of the HEART Risk Score in Chest Pain Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual Care n=1827 Participants standard care of the cardiologist according to current cardiological guidelines	HEART Care n=1821 Participants standard care of the cardiologist according to current cardiological guidelines, complemented by calculation of the HEART score and following the recommended policy	Total n=3648 Participants Total of all reporting groups
Age, Continuous	62 years STANDARD_DEVIATION 14 • n=5 Participants	62 years STANDARD_DEVIATION 14 • n=7 Participants	62 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	822 Participants n=5 Participants	846 Participants n=7 Participants	1668 Participants n=5 Participants
Sex: Female, Male Male	1005 Participants n=5 Participants	975 Participants n=7 Participants	1980 Participants n=5 Participants
Region of Enrollment Netherlands	1827 Participants n=5 Participants	1821 Participants n=7 Participants	3648 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

occurrence of major adverse cardiac events (MACE, i.e. acute myocardial infarction (AMI), Percutaneous Coronary Intervention (PCI), Coronary Artery Bypass Grafting (CABG) or death) within 6 weeks after presentation

Outcome measures

Outcome measures
Measure	Usual Care n=1827 Participants usual care was defined as daily practice of the cardiologist or attending emergency doctor, in order to diagnose a patient with chest pain. In this period attending doctors assess the risk of a patient with chest pain, based on his/hers experience and various criteria (for example described in European Society of Cardiology Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation, without a formal risk score).	HEART Care n=1821 Participants HEART care: usual care, complemented by calculation of the HEART score and following the recommended policy.
MACE (Major Adverse Cardiac Events)	405 Participants	345 Participants

SECONDARY outcome

Timeframe: 3 months

Population: Cost-effectiveness analysis was performed in 5 of 9 hospitals

Information on quality of life (QoL) and costs was collected in 5 of the 9 hospitals. Costs for health care resource use were calculated based on Dutch guidelines and cost tables for hospitals. Different costs were used for academic and general hospitals, and costs were adjusted for inflation by using the consumer price indices provided by Statistics Netherlands. For each patient the costs were calculated based on the observed number and type of health care resources used and the type of hospital (academic/general). Data on resource use were collected for each patient in the 5 hospitals; no data were missing. QoL was derived from the EQ-5D-3L questionnaire, consisting of 5 questions (dimensions) with 3 answers each, from which QoL scores (utility values, 0-1, the higher the better) can be directly derived. Quality-adjusted life-years (scale 0-100, higher the better) were calculated over a period of 3 months, based on the estimated QoL values at 0 weeks, 2 weeks, and 3 months.

Outcome measures

Outcome measures
Measure	Usual Care n=1176 Participants usual care was defined as daily practice of the cardiologist or attending emergency doctor, in order to diagnose a patient with chest pain. In this period attending doctors assess the risk of a patient with chest pain, based on his/hers experience and various criteria (for example described in European Society of Cardiology Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation, without a formal risk score).	HEART Care n=804 Participants HEART care: usual care, complemented by calculation of the HEART score and following the recommended policy.
Cost-effectiveness (Costs, QoL, QALYs)	0.16 years Interval 0.16 to 0.17	0.17 years Interval 0.17 to 0.18

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

with a women-specific questionnaire, we hope to identify risk factors specific for women (pregnancy diabetes/hypertension, Poly Cystic Ovarial Syndrome (PCOS), etc)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 weeks

To assess whether the effectiveness and/or safety of using the HEART (history, ecg, age, risk factors, troponin) score (scale 0-10, with higher scores meaning a higher risk on MACEs) is different between specific patient populations, the following pre-specified subgroup analyses will be performed: Age: below and above 62 years of age (median), Gender: Men vs Women, Diabetics vs non-diabetics, Ethnicity: Caucasian vs. other ethnicity. RESULTS: None of the pre-specified subgroup analyses of women, elderly patients, and diabetic patients showed a statistically significantly different effect of HEART care with respect to incidence of MACEs. Ethnicity was unfortunately not possible to analyse due to too much missing data. NB. I am currently not working in the organisation which has the data, and this will not be possible the coming period. Therefore, I cannot provide correct numbers currently on these subgroup analyses, only conclusions. I am sorry for this inconvenience.

Outcome measures

Outcome data not reported

Adverse Events

Usual Care

Serious events: 405 serious events

Other events: 0 other events

Deaths: 9 deaths

HEART Care

Serious events: 345 serious events

Other events: 0 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	Usual Care n=1827 participants at risk usual care was defined as daily practice of the cardiologist or attending emergency doctor, in order to diagnose a patient with chest pain. In this period attending doctors assess the risk of a patient with chest pain, based on his/hers experience and various criteria (for example described in European Society of Cardiology Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation, without a formal risk score).	HEART Care n=1821 participants at risk HEART care: usual care, complemented by calculation of the HEART score and following the recommended policy. During 14 months, patients presenting with chest pain to the ED of participating hospitals were included in the study. First, all hospitals applied 'usual care' to all patients, i.e. risk assessment and subsequent management without application of the HEART score. Then, during a 14 month period, each 1,5 month 1 randomly allocated hospital sequentially started to apply the HEART score in all chest pain patients (intervention period); during this intervention period patients with a HEART score 0-3 were advised not be admitted to the hospital, and patients with a HEART score above 3 were advised to be treated according to current guidelines.
Cardiac disorders Cardiac ischemia	21.9% 400/1827 • Number of events 400 • 6 weeks	18.1% 329/1821 • Number of events 329 • 6 weeks
Cardiac disorders Death	0.49% 9/1827 • Number of events 9 • 6 weeks	0.27% 5/1821 • Number of events 5 • 6 weeks
Cardiac disorders Significant stenosis (PCI, CABG, conservative)	15.9% 290/1827 • Number of events 290 • 6 weeks	13.6% 247/1821 • Number of events 247 • 6 weeks

Other adverse events

Adverse event data not reported

Additional Information

Dr. Judith Poldervaart

University Medical Center Utrectht

Phone: 008875 55105

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place